Medical devices; Spanish-language version of certain required statements.

21 C.F.R. § 801.16
in effectEffective: 2024-07-01
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If devices restricted to prescription use only are labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico where Spanish is the predominant language, such labeling is authorized under § 801.15(c).

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21 C.F.R. § 801.16 — Medical devices; Spanish-language version of certain required statements | Code of Federal Regulations | Corpus